Back to resultsInnovative Strategies to Increase ART Initiation and Viral Suppression Among HIV-positive Men in Malawi
Primary Purpose
Hiv
Status
Active
Phase
Not Applicable
Locations
Malawi
Study Type
Interventional
Intervention
Home-Based ART
Facility-Based ART
Sponsored by
About this trial
This is an interventional treatment trial for Hiv focused on measuring HIV, HIV Self-Testing, HIVST, Index HIVST, Index Testing, Men, Male Partners, Antiretroviral therapy, ART initiation, Home-based ART, ART retention
Eligibility Criteria
Female Partner Inclusion Criteria:
- Male partner ≥15 years of age
- No reported interpersonal violence (IPV) as defined by World Health Organization (WHO) with the above male partner in the past 12-months
- Male partner ever tested HIV-positive
Male partner not currently engaged in ART services, defined as:
- Tested HIV-positive ≥14 days and not on ART ≥14 days after testing HIV- positive;
- ≥14 days late for the first four-week follow up appointment; or
- Initiated ART but ≥60 days late for last ART appointment;
- Male partner living inside the facility catchment area (defined as any area that Healthcare Workers (HCWs) from the study facility routinely visit for tracing purposes)
Female Partner Exclusion Criteria:
- Male partner <15 years of age
- Reported interpersonal violence (IPV) as defined by WHO with the above male partner in the past 12-months
- Male partner never tested HIV positive
- Male partner tested HIV-positive <14 days ago
Male partner currently engaged in ART services, defined as:
- Initiated ART <14 days late for the first four-week follow up appointment
- Initiated ART and <60 days late for last ART appointment
- Male partner living outside the facility catchment area (defined as any area that HCWs from the study facility routinely visit for tracing purposes)
Men Living with HIV Inclusion Criteria:
- ≥15 years of age
- Tested HIV positive using Ministry of Health standard algorithm (Determine + Unigold)
Not currently engaged in ART services, defined as:
- Tested HIV-positive ≥14 days and not on ART ≥14 days after testing HIV-positive;
- ≥14 days late for the first four-week follow up appointment; or
- Initiated ART but ≥60 days late for last ART appointment;
- Has not taken ART in the past 7-days, as indicated by a point of care (POC) urine assay
- Living inside the facility catchment area (defined as any area that HCWs from the study facility routinely visit for tracing purposes)
Men Living with HIV Exclusion Criteria:
- <15 years of age
- Never tested HIV positive using Ministry of Health standard algorithm (Determine + Unigold)
- Tested HIV-positive <14 days ago
Currently engaged in ART services, defined as:
- Initiated ART
- <14 days late for the first four-week follow up appointment
- Initiated ART and <60 days late for last ART appointment
- Has taken ART in the past 7-days, as indicated by a point of care (POC) urine assay
- Living outside the facility catchment area (defined as any area that HCWs from the study facility routinely visit for tracing purposes)
Sites / Locations
- Partners in Hope
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
hbART
fbART
Arm Description
Home-Based ART initiation and continuation for 3-months with male-specific counseling and assisted facility navigation at 4-months.
Facility-Based ART initiation and continuation with male-specific counseling.
Outcomes
Primary Outcome Measures
Men's ART Initiation
ART initiation within 6-months of enrollment. Sourced from medical chart reviews.
Secondary Outcome Measures
Men's 6-month Retention
6-month retention (<60 days ever late for ART). Sourced from medical chart reviews.
Full Information
NCT ID
NCT04878601
First Posted
May 4, 2021
Last Updated
June 23, 2023
Sponsor
University of California, Los Angeles
Collaborators
Partners in Hope, Malawi, Fogarty International Center of the National Institute of Health
1. Study Identification
Unique Protocol Identification Number
NCT04878601
Brief Title
Innovative Strategies to Increase ART Initiation and Viral Suppression Among HIV-positive Men in Malawi
Official Title
Innovative Strategies to Increase ART Initiation and Viral Suppression Among HIV-positive Men in Malawi
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
Partners in Hope, Malawi, Fogarty International Center of the National Institute of Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Men in Sub-Saharan Africa are less likely to test for HIV, initiate ART, and more likely to initiate ART at later stages of disease. Two overarching barriers keep HIV-positive men from accessing ART services: 1) Lack of male-friendly services, and 2) harmful gender norms. Home-based ART may improve ART initiation and retention among male partners who test HIV-positive through Index HIV self-testing (HIVST). We will pilot an intervention that provides home-based ART initiation and home-based continuation for 3-months, followed by assisted linkage to facility-based care at 4-months. 470 participants will be enrolled [209 females, 261 males]
Detailed Description
Men in Sub-Saharan Africa are less likely to test for HIV, initiate ART, and more likely to initiate ART at later stages of disease. Achieving epidemic control requires immediate, concentrated effort to engage this largely unreached population. Index partner testing, whereby partners of HIV-positive clients are refereed for HIV testing, is critical to identifying undiagnosed men and has been adopted as a national policy by the Malawi Ministry of Health because of its high acceptability and its dramatic increase on HIV testing uptake. Two overarching barriers keep HIV-positive men from accessing ART services: 1) Lack of male-friendly services, and 2) harmful gender norms. Home-based ART may improve ART initiation and retention among male partners who test HIV-positive through Index HIVST. We will pilot an intervention that provides home-based ART initiation and home-based continuation for male partners identified as HIV-positive through Index HIVST for 3-months, followed by assisted linkage to facility-based care at 4-months. This intervention offers opt-out ART and in-depth, male-specific counseling for 3-months before linking men to facility based care. We will directly compare home-based ART to facility-based ART, whereby a health care worker will conduct a home-visit with HIV+ male partners to provide confirmatory HIV testing and immediate assisted linkage to a nearby facility for facility-based ART initiation and continuation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hiv
Keywords
HIV, HIV Self-Testing, HIVST, Index HIVST, Index Testing, Men, Male Partners, Antiretroviral therapy, ART initiation, Home-based ART, ART retention
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
470 (Actual)
8. Arms, Groups, and Interventions
Arm Title
hbART
Arm Type
Experimental
Arm Description
Home-Based ART initiation and continuation for 3-months with male-specific counseling and assisted facility navigation at 4-months.
Arm Title
fbART
Arm Type
Active Comparator
Arm Description
Facility-Based ART initiation and continuation with male-specific counseling.
Intervention Type
Other
Intervention Name(s)
Home-Based ART
Intervention Description
Healthcare provider will ask ART client for permission to conduct a home visit with their HIV+ partner. Providers will conduct a home visit with HIV+ partners to provide confirmatory HIV testing and ART initiation with a 30-day supply. Monthly home-based ART follow-up visits with male-specific messaging and 30-day supply distribution will take place for 3-months. At 4-months providers will provide assisted linkage to a nearby facility to join the facility-based ART program. Additional counseling will be provided.
Intervention Type
Other
Intervention Name(s)
Facility-Based ART
Intervention Description
Healthcare provider will ask ART client for permission to conduct a home visit with their HIV+ partner. Providers will conduct a home visit with HIV+ partners to provide confirmatory HIV testing and assisted linkage to a nearby facility for facility-based ART initiation and continuation. Male clients will receive a 30-day supply each visit and return monthly.
Primary Outcome Measure Information:
Title
Men's ART Initiation
Description
ART initiation within 6-months of enrollment. Sourced from medical chart reviews.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Men's 6-month Retention
Description
6-month retention (<60 days ever late for ART). Sourced from medical chart reviews.
Time Frame
6 months
10. Eligibility
Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Female Partner Inclusion Criteria:
Male partner ≥15 years of age
No reported interpersonal violence (IPV) as defined by World Health Organization (WHO) with the above male partner in the past 12-months
Male partner ever tested HIV-positive
Male partner not currently engaged in ART services, defined as:
Tested HIV-positive ≥14 days and not on ART ≥14 days after testing HIV- positive;
≥14 days late for the first four-week follow up appointment; or
Initiated ART but ≥60 days late for last ART appointment;
Male partner living inside the facility catchment area (defined as any area that Healthcare Workers (HCWs) from the study facility routinely visit for tracing purposes)
Female Partner Exclusion Criteria:
Male partner <15 years of age
Reported interpersonal violence (IPV) as defined by WHO with the above male partner in the past 12-months
Male partner never tested HIV positive
Male partner tested HIV-positive <14 days ago
Male partner currently engaged in ART services, defined as:
Initiated ART <14 days late for the first four-week follow up appointment
Initiated ART and <60 days late for last ART appointment
Male partner living outside the facility catchment area (defined as any area that HCWs from the study facility routinely visit for tracing purposes)
Men Living with HIV Inclusion Criteria:
≥15 years of age
Tested HIV positive using Ministry of Health standard algorithm (Determine + Unigold)
Not currently engaged in ART services, defined as:
Tested HIV-positive ≥14 days and not on ART ≥14 days after testing HIV-positive;
≥14 days late for the first four-week follow up appointment; or
Initiated ART but ≥60 days late for last ART appointment;
Has not taken ART in the past 7-days, as indicated by a point of care (POC) urine assay
Living inside the facility catchment area (defined as any area that HCWs from the study facility routinely visit for tracing purposes)
Men Living with HIV Exclusion Criteria:
<15 years of age
Never tested HIV positive using Ministry of Health standard algorithm (Determine + Unigold)
Tested HIV-positive <14 days ago
Currently engaged in ART services, defined as:
Initiated ART
<14 days late for the first four-week follow up appointment
Initiated ART and <60 days late for last ART appointment
Has taken ART in the past 7-days, as indicated by a point of care (POC) urine assay
Living outside the facility catchment area (defined as any area that HCWs from the study facility routinely visit for tracing purposes)
Facility Information:
Facility Name
Partners in Hope
City
Lilongwe
Country
Malawi
12. IPD Sharing Statement
Learn more about this trial
Innovative Strategies to Increase ART Initiation and Viral Suppression Among HIV-positive Men in Malawi
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